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EVEROLIMUS


DIR Classification


Classification:Moderate-DIR concern
Severity Score:3

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • In a randomized, placebo-controlled, cross-over study, 59 healthy subjects were administered a single oral dose of Everolimus (20 mg and 50 mg) and placebo. Everolimus at single doses up to 50 mg did not prolong the QT/QTc interval.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
42
42870
Other ADRs
24505
14092774

Odds Ratio = 0.564

Drug Property Information



ATC Code(s):
  • L01XE10 - everolimus
    • L01XE - Protein kinase inhibitors
    • L01X - OTHER ANTINEOPLASTIC AGENTS
    • L01 - ANTINEOPLASTIC AGENTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
  • L04AA18 - everolimus
    • L04AA - Selective immunosuppressants
    • L04A - IMMUNOSUPPRESSANTS
    • L04 - IMMUNOSUPPRESSANTS
    • L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:everolimus
Active Ingredient UNII:9HW64Q8G6G
Drugbank ID:DB01590
PubChem Compound:6442177
CAS Number:159351-69-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
  • 1.5 mg/day L04AA18
Chemical Structure:
SMILE Code:
C[C@@H]1CC[C@H]2C[C@@H](/C(=C/C=C/C=C/[C@H](C[C@H](C(=O)[C@@H]([C@@H](/C(=C/[C@H](C(=O)C[C@H](OC(=O)[C@@H]3CCCCN3C(=O)C(=O)[C@@]1(O2)O)[C@H](C)C[C@@H]4CC[C@H]([C@@H](C4)OC)OCCO)C)/C)O)OC)C)C)/C)OC

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Ezetimibe is effective in the treatment of persistent hyperlipidemia of renal allograft recipients.

[Savvidaki E,Koukoulaki M,Benou A,Roumeliotou M,Fourtounas C,Kalliakmani P,Papachristou E,Vlachojannis J G,Goumenos D]
Clin Nephrol.2011 Feb;75(2):107-12. PMID: 21255539

2: Regression of subependymal giant cell astrocytomas with RAD001 (Everolimus) in tuberous sclerosis complex.

[Yalon Michal,Ben-Sira L,Constantini S,Toren A]
Childs Nerv Syst.2011 Jan;27(1):179-81. doi: 10.1007/s00381-010-1222-y. Epub 2010 Aug 12. PMID: 20703486

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